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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | taselisib (GDC-0032) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Excerpt:
...- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing...
Trial ID:
Source:
Title:
A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Excerpt:
...- Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer - Recurrence or progression during or after aromatase inhibitor - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas® PIK3CA mutation result by central testing is required - Adequate hematologic and end-organ function within 28 days prior to treatment initiation ...
More C2 evidence
Source:
Title:
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Excerpt:
...- Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol...
Trial ID:
Source:
Title:
A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
Excerpt:
...- Phase I (Cohort T): Participants with non-Hodgkin's lymphoma, regardless of PIK3CA mutation status...
Trial ID:
Source:
Title:
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
Excerpt:
...- Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory...
Trial ID:
Less C2 evidence
Source:
Title:
Test measuring signaling activity in live patient tumor cells to identify PI3KCA WT patients who may benefit from PI3K inhibitors.
Published date:
05/28/2020
Excerpt:
For the xenograft study, 16 NSG mice were injected with HCC1954 PIK3CA mutated breast cancer cells and randomly assigned to either the control or taselisib group (10 mg/kg)….The xenograft study reported here using HCC1954 cells found taselisib induces a significant anti-tumor effect (T/C ratio = 0.21; p = 0.009; t-test).
DOI:
10.1200/JCO.2020.38.15_suppl.e13000
